Cleared Traditional

K142768 - Instru-Safe Instrument Protection System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142768 · Summit Medical, Inc. · General Hospital
May 2015
Decision
246d
Days
Class 2
Risk

K142768 is an FDA 510(k) clearance for the Instru-Safe Instrument Protection System. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Summit Medical, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 246 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K142768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date May 29, 2015
Days to Decision 246 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 170d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 25
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K142768.
PUREVUE™ Quick Connect Cannula System Tray
K253791 · DePuy Mitek, Inc. · Feb 2026
Stainless Steel Surgical Kits
K251614 · Dentsply Sirona, Inc. · Feb 2026
Sterilization Trays
K251756 · Paragon Implant Mfg., LLC · Nov 2025
Guided DAS Surgical Kit
K243425 · Talladium Espa?a, SL · Jul 2025
Plastic Surgical Kits
K251300 · Dentsply Sirona, Inc. · Jul 2025
PAL Sterilization Case
K243589 · Microaire Surgical Instruments, LLC · Jun 2025